Optimizing evidence-based HIV prevention targeting people who inject drugs on PrEP

针对 PrEP 注射吸毒者优化基于证据的艾滋病毒预防

基本信息

批准号：
10548320
负责人：
MICHAEL COPENHAVER
金额：
$ 60.56万
依托单位：
UNIVERSITY OF CONNECTICUT STORRS
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-01 至 2027-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10548320
关键词：
AIDS prevention AIDS/HIV problem Acquired Immunodeficiency Syndrome Adherence Alzheimer&apos s Disease American Analgesics Area Attention Attention deficit hyperactivity disorder Behavior Behavioral Budgets Centers for Disease Control and Prevention (U.S.)Characteristics Cognitive Cognitive deficits Communities Disease Outbreaks Enrollment Evidence based intervention Exhibits Funding Funding Opportunities Goals Guidelines HIV HIV Infections HIV risk Health Health Promotion Health behavior Health behavior change Impaired cognition Incidence Individual Injectable Injecting drug user Intervention Knowledge Measurement Measures Mediator of activation protein Memory Methods Modeling Motivation Neurologic Opioid Outcome Participant Patient Self-Report Patients Performance Persons Pharmaceutical Preparations Pharmacotherapy Prevention approach Process Public Health Recovery Research Research Priority Risk Behaviors Risk Reduction Risk Reduction Behavior Science Study models Traumatic Brain Injury United States National Institutes of Health Update Work base cognitive function cognitive testing comorbidity cost cost effectiveness design evidence base executive function experience follow-up frontier future implementation high risk population information processing innovation medication compliance memory process multiphase optimization strategy opioid epidemic opioid use disorder overdose death patient population post intervention pre-exposure prophylaxis prevent primary outcome programs response secondary outcome sex skills transmission process treatment program treatment services trend

项目摘要

Framed by the multiphase optimization strategy (MOST), and building on our recent preliminary studies, we are requesting 5 years of support to conduct an optimization trial among people who inject drugs (PWID) and newly enrolled on medication for opioid use disorder (MOUD). The goal is to assess the performance of four intervention components (Attention, Executive Functioning, Memory, and Information Processing) aimed at enhancing the ability of PWID on MOUD to process and utilize evidence-based HIV prevention content, leading to improvements in Pre-Exposure Prophylaxis (PrEP) adherence and HIV risk reduction. Existing evidence-based interventions require participants to have at least moderate levels of cognitive functioning but do not acknowledge or accommodate participants with cognitive dysfunction. This is a crucial weakness as cognitive dysfunction is a common feature among PWID, and one that can directly impede their ability to process and utilize intervention content. In fact, our recent studies comparing objective and self-report cognitive assessments (e.g., NIH toolbox) show that ~67% of PWID experience substantial levels of cognitive dysfunction across tasks involving attention, executive function, memory, and information processing that, in turn, disrupt the expected intervention outcomes (e.g., medication adherence, HIV risk reduction). Our recent work also suggests that PWID newly enrolled on MOUD would benefit from an intervention approach that incorporates ‘compensatory strategies’ to accommodate their cognitive dysfunction. A number of well-established compensatory strategies have been successfully applied to other patient populations (e.g., traumatic brain injury, ADHD, Alzheimer’s/dementia) and have been identified by our team as promising intervention components that could enhance evidence-based PrEP-focused primary HIV prevention approaches targeting PWID on MOUD. To date, however, no studies have examined the potential impact and cost of incorporating such intervention components, either individually or in various combinations, in terms of enhancing PWID’s ability to process and utilize HIV prevention content. This innovative trial will be the first to use the MOST framework to optimize an evidence-based HIV prevention approach by compensating for cognitive features that are characteristic of PWID on MOUD, and maximizing PrEP adherence outcomes within real world budget constraints.

由多相优化策略（大多数）构建，并在我们的最新初步研究，我们要求提供5年的支持，以进行优化试验注射药物（PWID）和新招收的阿片类药物使用障碍药物的人（moud）。目的是评估四个干预组件的性能（注意，执行功能，记忆和信息处理）旨在增强在MOUD上进行处理并利用基于证据的HIV预防含量，从而导致暴露前预防（PREP）依从性和HIV风险降低的改善。现存的基于证据的干预措施要求参与者至少具有中等水平的认知能力功能但不承认或接受具有认知功能障碍的参与者。这是一个至关重要的弱点，因为认知功能障碍是PWID的共同特征，一个这可以直接阻碍他们处理和利用干预内容的能力。实际上，我们的最近的研究比较目标和自我报告认知评估（例如NIH工具箱）证明约67％的PWID经历了跨任务的认知功能障碍的大量水平涉及注意，执行功能，内存和信息处理，反过来破坏预期的干预结果（例如，药物依从性，艾滋病毒风险降低）。我们最近的工作还表明，PWID新入学的穆德将从干预方法包含“补偿性策略”以适应其认知功能障碍。许多公认的补偿策略已经成功应用于其他患者人群（例如，创伤性脑损伤，多动症，阿尔茨海默氏症/痴呆症）并已被我们的团队确定为承诺的干预措施可以增强以证据为基础的预防原发性HIV预防的组件接近针对MOUD上的PWID的方法。但是，迄今为止，尚无研究检查单独或在各种组合中，就增强了PWID的处理能力和利用HIV的能力而言预防内容。这项创新的试验将是第一个使用最多的框架来优化的试验通过补偿认知特征的一种基于证据的艾滋病毒预防方法 PWID在MOUD上的特征，并最大程度地提高现实世界中的准备依从性结果预算限制。